Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study (NCT05727943) | Clinical Trial Compass
UnknownPhase 2
Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study
Belgium10 participantsStarted 2022-03-01
Plain-language summary
In this exploratory trial, the potential anti-seizure activity of clioquinol in a small cohort of adolescents with drug-resistant epilepsy will be examined. Subjects will be exposed to clioquinol add-on for a period of maximum 8 weeks (2 weeks low dose, 6 weeks higher dose). The main hypothesis of the study is that 30% of the included subjects will be responders and that the median seizure frequency reduction will be at least 30%.
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion criteria
✓. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
✓. In females with child bearing potential: negative pregnancy test or use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some intra-uterine devices, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomized partner
✓. Age ≥ 12 years and \< 18 years at time of inclusion
✓. Weight ≥ 20 kg at time of inclusion
✓. Well defined epilepsy history with convulsive seizures (with observable and countable motor component)
✓. Drug-resistant epilepsy: before inclusion failure of at least 2 AEDs
✓. Drug-resistant epilepsy: ≥ 4 seizures in the 2 week prospective period (baseline) before visit 2, not all (4) seizures observed in 1 of the 2 weeks. Baseline period can be extended with 1 or 2 weeks.
✓. The patient is at the moment of inclusion on max 3 anti-epileptic drugs (VNS and ketogenic diet not included)
Exclusion criteria
✕. Participant has a history of liver or kidney disease. Children with a co-existing active neuropathy (such as neuritis optica, transverse myelitis)
✕. Abnormal low blood level of vitamin B12 or Zn
✕. Patients with hypothyroidism
✕. Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol
✕. Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial
✕. Exposure to clioquinol before the trial
✕. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive